Postmenopausal Evaluation and Risk-reduction With Lasofoxifene (PEARL)

This study has been completed.
Sponsor:
Information provided by:
Ligand Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00141323
First received: August 30, 2005
Last updated: August 8, 2011
Last verified: August 2011
  Purpose

The purpose of the study is to determine the safety and effectiveness of 2 doses of the investigational drug, lasofoxifene, compared to placebo (an inactive substance) in reducing new spinal fractures in women with osteoporosis.


Condition Intervention Phase
Osteoporosis
Drug: lasofoxifene
Other: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: PEARL: Postmenopausal Evaluation And Risk-Reduction With Lasofoxifene

Resource links provided by NLM:


Further study details as provided by Ligand Pharmaceuticals:

Primary Outcome Measures:
  • New morphometric vertebral fractures [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • New cases of breast cancer [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • New non-vertebral fractures [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • All clinical fractures, non-vertebral fractures, BMD, breast cancer, cardiovascular events, and gynecological safety events [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • All clinical fractures, new morphometric vertebral fractures, BMD, cardiovascular events, and gynecological safety events [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 8556
Study Start Date: November 2001
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: lasofoxifene 0.5 mg/day Drug: lasofoxifene
0.5 mg once per day, orally
Placebo Comparator: placebo Other: placebo
placebo
Experimental: lasofoxifene 0.25 mg/day Drug: lasofoxifene
0.25 mg once per day, orally

  Eligibility

Ages Eligible for Study:   60 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Postmenopausal at least 5 years; Screening bone mineral density more than or equal to 2.5 S.D.s below the mean for young adults at the lumbar spine or femoral neck.

Exclusion Criteria:

Metabolic bone disease other than osteoporosis; Taking approved medications for osteoporosis; Have had a recent osteoporotic fracture (within 1 year) and/or have a bone mineral density more than 4.5 S.D.s below the mean for young adults at the lumbar spine or femoral neck.

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00141323

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Locations
United States, Alabama
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Birmingham, Alabama, United States, 35205
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Birmingham, Alabama, United States, 35216
United States, California
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La Jolla, California, United States, 92037
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La Jolla, California, United States, 92161
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La Jolla, California, United States, 92093-0659
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Palm Desert, California, United States, 92260
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Palm Springs, California, United States, 92263
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Palm Springs, California, United States, 92262
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Poway, California, United States, 94064
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Rancho Mirage, California, United States, 92270
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San Diego, California, United States, 92123
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San Diego, California, United States, 92128
United States, Florida
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Brandon, Florida, United States, 33611
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Leesburg, Florida, United States, 34748
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Tampa, Florida, United States, 33607
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Tampa, Florida, United States, 33613
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Tampa, Florida, United States, 33614
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West Palm Beach, Florida, United States, 33414
United States, Illinois
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Des Plaines, Illinois, United States, 60016
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Morton Grove, Illinois, United States, 60053
United States, Iowa
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Des Moines, Iowa, United States, 50309
United States, Maryland
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Bethesda, Maryland, United States, 20817
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Montgomery Village, Maryland, United States, 20886
United States, Minnesota
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Arden Hills, Minnesota, United States, 55112
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Minneapolis, Minnesota, United States, 55415-1226
United States, Nebraska
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Omaha, Nebraska, United States, 68131
United States, New Mexico
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Albuquerque, New Mexico, United States, 87106
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Albuquerque, New Mexico, United States, 87102
United States, Ohio
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Centerville, Ohio, United States, 45459
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Dayton, Ohio, United States, 45409
United States, Oregon
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Portland, Oregon, United States, 97239
United States, Pennsylvania
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Charleroia, Pennsylvania, United States, 15022
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Monessen, Pennsylvania, United States, 15062
United States, Tennessee
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Cordova, Tennessee, United States, 38018
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Memphis, Tennessee, United States, 38119
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Dallas, Texas, United States, 75230
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San Antonio, Texas, United States, 78229
United States, Virginia
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Richmond, Virginia, United States, 23227
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Richmond, Virginia, United States, 23225
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Richmond, Virginia, United States, 23229
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Richmond, Virginia, United States, 23235
United States, Washington
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Redmond, Washington, United States, 98052
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Seattle, Washington, United States, 98105-4631
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Seattle, Washington, United States, 98133
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Seattle, Washington, United States, 98195
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Seattle, Washington, United States, 98101-1448
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Seattle, Washington, United States, 98104
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Seattle, Washington, United States, 98112
Argentina
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Capital Federal, Buenos Aires, Argentina, C1117ABH
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Capital Federal, Buenos Aires, Argentina, C1114AAH
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Buenos Aires, Capital Federal, Argentina, C1287ACF
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Rosario, Santa Fe, Argentina, S2000DHL
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Rosario, Santa Fe, Argentina, S2000 DHL
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Rosario, Santa Fe, Argentina, s2000 DHL
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Capital Federal, Argentina, C1115AAJ
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Capital Federal, Argentina, C1428AQK
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Capital Federal - Buenos Aires, Argentina, C1012AAP
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S2000DHL- Rosario - Santa Fe, Argentina
Australia, New South Wales
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Concord, New South Wales, Australia, NSW 2139
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Randwick, New South Wales, Australia, 2031
Australia, South Australia
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Adelaide, South Australia, Australia, 5006
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Ashford, South Australia, Australia, 5035
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Dulwich, South Australia, Australia, 5065
Australia, Victoria
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Geelong, Victoria, Australia, 3220
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Heidelberg, Victoria, Australia, 3081
Australia, Western Australia
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Nedlands, Western Australia, Australia, WA 6009
Australia
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Randwick, Australia, NSW 2031
Belgium
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Genk, Belgium, 3590
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Leuven, Belgium, 3000
Brazil
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Sao Paulo, SP, Brazil, 04062-003
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Sao Paulo, SP, Brazil, 04013002
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Sao Paulo, SP, Brazil, 04230-000
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São Caetano do Sul, SP, Brazil, 09540-830
Canada, Alberta
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Calgary, Alberta, Canada, T2N 4N1
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Calgary, Alberta, Canada, T2N 2T9
Canada, British Columbia
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Vancouver, British Columbia, Canada, V5Z 3A6
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Vancouver, British Columbia, Canada, V5Z 3Y1
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Vancouver, British Columbia, Canada, V6H 3X8
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Winnipeg, Manitoba, Canada, R3A 1M3
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Hamilton, Ontario, Canada, L8N 1Y2
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Hamilton, Ontario, Canada, L8N 2B6
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Hamilton, Ontario, Canada, L8N 4A6
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Toronto, Ontario, Canada, M5C 2T2
Canada, Quebec
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Montreal, Quebec, Canada, H2X 1P1
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Montréal, Quebec, Canada, H5B 1B2
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Sainte-Foy, Quebec, Canada, G1V 3M7
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Sainte-foy, Quebec, Canada, G1V 4G2
Canada, Saskatchewan
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Saskatoon, Saskatchewan, Canada, S7K 0H6
Costa Rica
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Curridabat, San Jose, Costa Rica
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Paseo Colon, San Jose, Costa Rica
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San Pedro, San Jose, Costa Rica
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Cartago, Costa Rica
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Escazu, Costa Rica
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San Jose, Costa Rica
Croatia
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Zagreb, Croatia, 10000
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Zagreb, Croatia, 10.000
Denmark
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Aarhus C, Denmark, 8000
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Hvidovre, Denmark, DK-2650
Egypt
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Cairo, Egypt
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Heliopolis, Cairo, Egypt
Estonia
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Parnu, Estonia, 80010
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Tallin, Estonia, 11312
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Tallin, Estonia, 13419
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Tallinn, Estonia, 10138
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Tartu, Estonia, 50410
Finland
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Helsinki, Finland, FIN-00100
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Oulu, Finland, FIN-90100
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Turku, Finland, 20100
France
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Lyon, France, 69003
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Lyon Cedex 03, France, 69437
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Paris Cedex 14, France, 75674
Germany
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Berlin, Germany, 12203
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Berlin, Germany, 12200
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Muenchen, Germany, 80809
Hong Kong
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Shatin, New Territories, Hong Kong
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New Territories, Hong Kong
Hungary
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Budapest, Hungary, H-1088
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Budapest, Hungary, H-1082
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Debrecen, Hungary, H-4012
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Gyor, Hungary, H-9024
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Gyor, Hungary, H-9023
India
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Hyderabad, Andhra Pradesh, India, 500 033
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Bangalore, Karnataka, India, 560-054
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Thiruvananthapuram, Kerala, India, 695 011
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Matunga (East), Mumbai, India
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Jaipur, Rajasthan, India, 302017
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Chennai, Tamil Nadu, India, 600 014
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Chennai, Tamil Nadu, India, 600 035
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Vellore, Tamil Nadu, India, 632004
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Jaipur, India, 302017
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New Delhi, India, 110 029
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Parel, Mumbai, India, 400 012
Ireland
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Dublin, Ireland, 2
Italy
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Firenze, Italy, 50139
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Firenze, Italy, 50134
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Verona, Italy, 37034
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Verona, Italy, 37122
Japan
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15-3-1 Maki Ohita-shi, Ohita-ken, Japan
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2-7-8 Yoyogi Shibuya-ku, Tokyo, Japan
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Shinjuku-ku, Tokyo, Japan
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Ohita, Japan
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Tokyo, Japan
Korea, Republic of
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Seoul, Korea, Korea, Republic of, 100-380
Lithuania
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Kaunas, Lithuania, LT-3007
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Kaunas, Lithuania, LT-50009
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Klaipeda, Lithuania, LT-92288
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Vilnius, Lithuania, LT-2600
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Vilnius, Lithuania, LT-10318
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Vilnius, Lithuania, LT-2055
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Vilnius, Lithuania, LT-01102
Mexico
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Mexico, DF, Mexico, 14050
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Tlalpan, Mexico City, Mexico, 14000
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Cp 11800, Mexico Df, Mexico
Norway
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Bergen, Norway, 5012
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Hamar, Norway, 2318
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Hamar, Norway, 2300
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Hamar, Norway, 2317
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Oslo, Norway, 0164
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Oslo, Norway, 0176
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Paradis, Norway, 5231
Poland
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Nowogrodzka 62A, Warszawa, Poland, 02-002
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Krakow, Poland, 30-315
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Krakow, Poland, 31-501
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Kraków, Poland, 31-501
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Warsaw, Poland, 00-416
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Warsaw, Poland, 00-719
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Warsaw, Poland, 02-634
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Warsaw, Poland, 02-380
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Warszawa, Poland, 00-416
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Warszawa, Poland, 02-341
Romania
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Timisoara, Timis, Romania, 1900
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Bucharest, Romania, 70231
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Bucharest, Romania
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Bucuresti, Romania, 762511
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Iasi, Romania, 6600
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Timisoara, Romania
Russian Federation
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Moscow, Russian Federation, 117036
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Moscow, Russian Federation, 115478
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Moscow, Russian Federation, 115522
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Moscow, Russian Federation, 101953
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Moscow, Russian Federation, 117815
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Moscow, Russian Federation
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St. Petersburg, Russian Federation, 199034
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St. Petersburg, Russian Federation, 190008
South Africa
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Bloemfontein, South Africa, 9300
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Cape Town, South Africa, 7500
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Cape Town, South Africa, 7129
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Johannesburg, South Africa, 2196
Spain
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Barcelona, Spain, 08025
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Madrid, Spain, 28041
Sweden
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Goteborg, Sweden, 411 32
Turkey
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Ankara, Turkey, 06590
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Izmir, Turkey, 35100
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Izmir, Turkey
United Kingdom
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Harrow, Middlesex, United Kingdom, HA1 3UJ
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Harrow, Middlesex, United Kingdom, HA1 3RX
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Northwood, Middlesex, United Kingdom, HA6 2RN
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Stanmore, Middlesex, United Kingdom, HA7 4LP
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Aberdeen, Scotland, United Kingdom, AB25 2ZN
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Aberdeen, Scotland, United Kingdom, AB25 1LD
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Aberdeen, Scotland, United Kingdom, AB25 2ZD
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Northwood, Middlesex, United Kingdom, HA6 2RN
Sponsors and Collaborators
Ligand Pharmaceuticals
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Ligand Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Director, Project Management, Ligand Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00141323     History of Changes
Other Study ID Numbers: A2181002
Study First Received: August 30, 2005
Last Updated: August 8, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on August 21, 2014